Zofran Lawsuit Demands Compensation for Death of Child

Parents from Texas recently filed a lawsuit against the makers of Zofran, claiming that the drug caused heart defects. The case, which is proceeding in the U.S. District Court for the District of Delaware, is a little unusual compared to other Zofran lawsuits in that the parents claim that Zofran was responsible for the death of one daughter and the birth defects of another.

The parents demand that the defendants, GlaxoSmithKline (GSK), pay damages in excess of $75,000 and they also request that the defendants be ordered to change the label on Zofran to include warnings regarding the alleged risks of the drug when taken during pregnancy.

About Zofran

Zofran is an anti-nausea medication. It was approved for use by the FDA in 1991 for the treatment of nausea in cancer patients who were undergoing radiation therapy or chemotherapy. However, physicians may also prescribe Zofran to women who are pregnant and are suffering from morning sickness. The off-label use of medications is a common practice in the healthcare field.

However, some concerns have been raised regarding the safety profile of Zofran when used by pregnant women.

Both daughters suffered severe birth defects

The plaintiff became pregnant with the first daughter in November of 2000. She had an ultrasound exam, which the lawsuit reports did not show signs of heart defects or any other abnormalities. At some point after undergoing the ultrasound, the plaintiff was prescribed Zofran for the treatment of morning sickness. She began taking it as prescribed on January 12, 2000. Subsequently, the plaintiff underwent diagnostic testing, which revealed severe physical malformations. These abnormalities included life-threatening heart defects, which the parents claim were the result of the mother’s use of Zofran.

Since the child was considered to be a high-risk birth, the plaintiff underwent a C-section on July 12, 2000, with pediatric cardiac specialists waiting to administer treatment to the child. Instead of being able to hold her newborn child, the plaintiff saw the daughter immediately transferred to a children’s hospital and placed on a ventilator. The child remained in the neonatal intensive care unit (NICU) until she died on August 2, 2000 as a result of having a severely malformed aorta and a heart that was only one-fifth of its normal size on the left side. During her short life, the child underwent multiple surgeries.

In May of 2002, the plaintiff again became pregnant with a daughter. She suffered from morning sickness and her physician prescribed Zofran again. Like the first daughter, this child was classified as a high-risk birth. The child was born in February of 2003 at a Texas hospital. Immediately after delivery, the child displayed excessive vomiting, reflux, and an inability to ingest nutrition. She required extended hospitalization and underwent a battery of tests before being diagnosed with congenital kidney defects and reflux.

The plaintiffs claim that Zofran was directly responsible for the death of their first daughter and the birth defects of their second child. They underwent genetic testing, which revealed no genetic anomalies.

Plaintiffs demand damages, labeling changes

In addition to demanding compensatory damages in the Zofran heart defect lawsuit, the plaintiffs demand that the makers of Zofran be ordered to remove the pregnancy category B designation from the product label. They further demand that the court order GSK to “fully and accurately summarize the risks of using Zofran during pregnancy.”

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